| CTRI Number |
CTRI/2024/11/077373 [Registered on: 26/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess the efficacy and safety of oral tranexamic acid in the management of melasma refractory to conventional treatments |
|
Scientific Title of Study
|
Efficacy and safety of oral tranexamic acid in the management of refractory melasma: A prospective, interventional study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tulika Rai |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, B.H.U., VARANASI |
| Address |
Department of Dermatology and Venereology. Institute of Medical Sciences,
B.H.U., VARANASI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9161023651 |
| Fax |
|
| Email |
raitulika1323@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tulika Rai |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, B.H.U., VARANASI |
| Address |
Department of Dermatology and Venereology. Institute of Medical Sciences,
B.H.U., VARANASI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9161023651 |
| Fax |
|
| Email |
raitulika1323@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ankit Raj |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences, B.H.U., VARANASI |
| Address |
Department of Dermatology and Venereology. Institute of Medical Sciences,
B.H.U., VARANASI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8789571548 |
| Fax |
|
| Email |
ankitcmcvellore@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional-Institute of Medical Sciences, Banaras Hindu University, Varanasi |
|
|
Primary Sponsor
|
| Name |
Department of Dermatology Institute of Medical Sciences Banaras Hindu University Varanasi |
| Address |
Institute of Medical Sciences Banaras Hindu University Varanasi- 221005 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tulika Rai |
Institute of Medical Sciences, B.H.U., VARANASI |
Department of Dermatology and Venereology. Institute of Medical Sciences,
B.H.U., VARANASI
Varanasi
UTTAR PRADESH |
08789571548
raitulika1323@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE BANARAS HINDU UNIVERSITY INSTITUTE OF MEDICAL SCIENCES VARANASI INDIA- 221005 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L811||Chloasma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Oral tranexamic acid |
500mg once daily for 6 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and female patient in the age group of 20-50 years with facial melasma for atleast past 3 months and dissatisfied with the results.
2. Interest to participate in research.
3. Normal hemogram, liver function test, renal function test and coagulation profile |
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating women.
2. History of bleeding disorders.
3. History of deep vein thrombosis or pulmonary embolism.
4. Use of oral anticoagulant drugs.
5. Use of photosensitizing drugs such as non steroidal anti-inflammatory drugs, tetracycline, spironolactone, phenytoin, carbamazepine.
6. Use of oral contraceptive pills or hormone replacement therapy.
7. Known allergy to tranexamic acid.
8. Unrealistic expectations |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in mMASI score |
Reduction in mMASI score monthly for 6 months and for 3 months after stopping treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess any side effects during the course of treatment |
Monthly assessment of any side effects if any will be done. |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
05/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients aged 20-50 years diagnosed clinically with melasma and fulfilling the inclusion criteria will be included in the study.
Oral tranexamic acid 500mg will be given once daily for a duration of 6 months.
mMASI ( modified Melasma Area and Severity index )score will be assessed monthly during the treatment period of 6 months and for 3 months after stopping of treatment.
Side effects if any will be assessed during the treatment period. |